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Oral Appliance Therapy and Hypoglossal Nerve Stimulation as Non-PAP Treatment Alternatives for Obstructive Sleep Apnea: A Narrative Expert Review
Abstract
This perspective on alternatives to Positive Airway Pressure therapy for the treatment of obstructive sleep apnea summarizes the proceedings of a focus group that was conducted by the Sleep Research Society Foundation. This perspective is from a multi-disciplinary panel of experts from sleep medicine, dental sleep medicine, and otolaryngology that aims to identify the current role of Oral Appliance Therapy and hypoglossal nerve stimulation for the treatment of obstructive sleep apnea with emphasis on the U.S. practice arena. A secondary aim is to identify – from an implementation science standpoint -- the various barriers and facilitators for adoption of non-PAP treatment that includes access to care, multi-disciplinary expertise, reimbursement, regulatory aspects, current treatment guidelines, health policies and other factors related to delivery of care. The panel has contextualized the review with recent events – such as a large-scale PAP device recall compounded by supply chain woes of the pandemic -- and emerging science in the field of obstructive sleep apnea and offers solutions for multi-disciplinary approaches while identifying knowledge gaps and future research opportunities.
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Mandibular advancement devices (MADs) remain a popular non-invasive treatment modality for the management of obstructive sleep apnea (OSA). However, the occlusal side effects from long-term therapy may result in poor patient compliance and patient drop-outs. Hence, knowledge of the possible side effects of these devices on occlusion is necessary. This article attempts to systematically review the evidence available in support of the possible long-term effects of mandibular advancement therapy on occlusion in adult sleep apnea patients.
A detailed search was conducted for unpublished and published literature and their references in various electronic databases. A grey literature search was also performed. Studies until June 30, 2022, were selected. Randomized controlled trials, non-randomized trials, and cohort studies investigating the occlusal side effects of MADs for the treatment of snoring or OSA with a follow-up of at least four years were included. Study selection, data extraction, and risk of bias assessment were performed individually and in duplicate. The risk of bias was assessed by Cochrane tools for randomized and non-randomized studies. Fourteen studies were selected for the final qualitative analysis.
The side effects reported were upper incisor retroclination, lower incisor proclination, decreased overjet and overbite, and change in the total occlusal contact area.
The review concludes that long-term MAD therapy has statistically and clinically significant effects on occlusion.
Background:
Whether the COVID-19 pandemic impacts Positive Airway Pressure (PAP) adherence over the long-term is unknown and only preliminary short-term data have been reported.
Methods:
With the aim of describing the impact of the first and second waves of COVID-19 on PAP adherence during 2020 in France, we designed a cross-sectional study of Sleep-Apnea (SA)-patients under PAP telemonitoring. To examine PAP adherence in adult SA patients, we assessed de-identified data from a non-profit healthcare provider database during the period January 1, 2019 to December 31, 2020. Included patients met the following criteria: (i) PAP-treated for at least 4 months before January 1, 2019 and with continuous PAP during both 2019 and 2020; (ii) ≥ 360 daily PAP telemonitored data per year. For PAP adherence, data were collected using the PAP-software.
Results:
8477/10482 patients were finally included in the analysis [72.4% male, median age 70 years (IQ25-75: 61-77], 25.6% < 62 years old, initial Apnea-Hypopnea Index (AHI) of 41 (31-59)/h. Median PAP adherence was 7.21 (6.12-8.10) h/day in 2020 versus 7.12 (6.05-8.02) h/day in 2019, p < 0.001. The median difference in PAP adherence between the first 2020 lockdown and the corresponding 2019 weeks was 9.75 (CI95% 8.75-10.75) min/day, p < 0.001. The median difference in PAP adherence between the second 2020 lockdown and the corresponding 2019 weeks was 5.00 (CI95% 4.00-6.00) min/day, p < 0.001. If we consider the minimal clinically important difference of 30 min for PAP adherence, 30.4% and 26% of the patients increased their PAP adherence by at least 30 min during the first and second lockdowns respectively; 17.6% and 19.3% of the patients lowered their PAP adherence by at least 30 min in the first and second lockdowns, respectively.
Conclusion:
During the first and second lockdowns, the COVID-19 pandemic had a clinically irrelevant effect on PAP adherence for the study population. Future studies are needed to describe COVID-19 pandemic impact on PAP adherence not only for long-term PAP-treated SA patients but also for incident cases. Trial registration The COVADENE study was registered on March 1st, 2021 on ClinicalTrials.gov (Identifier: NCT04775966).
Background
Continuous positive airway pressure (CPAP) is the gold standard of care in providing non-invasive positive pressure support to neonates in respiratory distress in high-resource settings. While safety has been demonstrated in low-resource settings, there is a lack of knowledge on the barriers and facilitators to proper implementation.
Objective
To identify and describe the barriers, facilitators, and priorities for future implementation of CPAP for neonates and infants in low-resource settings.
Methods
A systematic search (database inception to March 6, 2020) was performed on MEDLINE, Embase, Web of Science, CINAHL, Global Health, and the WHO Global Index Medicus using PRISMA-ScR guidelines. Original research articles pertaining to implementation of CPAP devices in low-resource settings, provider or parent perspectives and experiences with CPAP, cost-benefit analyses, and cost-effectiveness studies were included. Inductive content analysis was conducted.
Findings
1385 article were screened and 54 studies across 19 countries met inclusion criteria. Six major themes emerged: device attributes, patient experiences, parent experiences, provider experiences, barriers, and facilitators. Nasal trauma was the most commonly reported complication. Barriers included unreliable electricity and lack of bioengineering support. Facilitators included training, mentorship and empowerment of healthcare providers. Device design, supply chain infrastructure, and training models were imperative to the adoption and sustainability of CPAP.
Conclusion
Sustainable implementation of CPAP in low resource settings requires easy-to-use devices, ready access to consumables, and holistic, user-driven training. Further research is necessary on standardizing metrics, interventions that support optimal provider performance, and conditions needed for successful long-term health system integration.
Background:
Hypoglossal nerve stimulation (HNS) with Inspire is a novel treatment indicated for moderate or severe obstructive sleep apnoea/hypopnoea syndrome (OSAHS), intolerant to or unable to be treated with continuous positive airway pressure (CPAP).
Objective:
The aim of this study was to assess the cost effectiveness of treating moderate or severe OSAHS, in patients intolerant to CPAP, with HNS, compared with standard care, from a National Health Service (NHS) perspective.
Methods:
A cohort state transition model was developed to compare HNS with Inspire with no treatment in UK adult patients with moderate or severe OSAHS who have previously tried and have not responded to CPAP therapy. Published literature was applied in the model to estimate incremental cost-effectiveness ratios (ICERs; 2019 Great British pounds per quality-adjusted life-year [QALY] gained), from an NHS and personal social services (PSS) perspective, over a cohort's lifetime.
Results:
The model base-case predicts that patients undergoing HNS will incur lifetime costs of £65,026 compared with £36,727 among untreated patients. The HNS cohort would gain 12.72 QALYs compared with 11.15 QALYs in the no-treatment arm. The ICER of treating severe OSAHS with HNS is therefore estimated to be £17,989 per QALYs gained. Probabilistic sensitivity analysis found that at a threshold of £30,000/QALY, HNS has a 69% probability of being cost effective. Limitations of the model include uncertainty around the utility data that were not sourced directly from HNS clinical trials. There is further uncertainty in the relationship between change in the Apnoea-Hypopnoea Index (AHI) and reduction in ischaemic heart disease and stroke because of difficulty capturing the reduction in risk over a long time horizon in studies.
Conclusions:
Over a patient's lifetime, HNS with Inspire is expected to be cost effective when compared with no treatment in patients with severe OSAHS who have tried and have not responded to CPAP, from an NHS perspective.
Study Objectives: Evaluating daytime neuromuscular electrical training (NMES) of tongue muscles in individuals with Primary Snoring and Mild Obstructive Sleep Apnea (OSA). Methods: A multicenter prospective study was undertaken in patients with primary snoring and mild sleep apnea where daytime NMES (eXciteOSA® Signifier Medical Technologies Ltd, London W6 0LG, UK) was used for 20 min once daily for 6 weeks. Change in percentage time spent snoring was analyzed using a two-night sleep study before and after therapy. Participants and their bed partners completed sleep quality questionnaires: Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI), and the bed partners reported on the nighttime snoring using a Visual Analogue Scale (VAS). Results: Of 125 patients recruited, 115 patients completed the trial. Ninety percent of the study population had some reduction in objective snoring with the mean reduction in the study population of 41% (p < 0.001). Bed partner-reported snoring reduced significantly by 39% (p < 0.001). ESS and total PSQI scores reduced significantly (p < 0.001) as well as bed partner PSQI (p = 0.017). No serious adverse events were reported. Conclusions: Daytime NMES (eXciteOSA®) is demonstrated to be effective at reducing objective and subjective snoring. It is associated with effective improvement in patient and bed partner sleep quality and patient daytime somnolence. Both objective and subjective measures demonstrated a consistent improvement. Daytime NMES was well tolerated and had minimal transient side effects.
Obstructive sleep apnea (OSA) is a common sleep disorder that affects all age groups and is associated with many co-morbid diseases (especially cardiovascular diseases). Continuous positive airway pressure (CPAP) is the gold standard for treating OSA. However, adherence to PAP therapy has been a major challenge with an estimated adherence between 20 and 80%. Mandibular advancement devices (MAD) are a good alternative option if used in the appropriate patient. MAD are most effective in mild and moderate OSA but not severe OSA. Surgical options are invasive, not appropriate for severe OSA, and associated with pain and long healing time. Hypoglossal nerve stimulation (HGNS), or upper airway stimulation (UAS), is a novel therapy in treating moderate and severe degrees of OSA in patients who cannot tolerate CPAP therapy. We reviewed the MEDLINE (PubMed) database. The search process yielded 303 articles; 31 met the inclusion and exclusion criteria and were included. We concluded that hypoglossal nerve stimulation is a very effective and novel alternative therapy for moderate and severe OSA in patients who cannot tolerate CPAP therapy. Adherence to HGNS is superior to CPAP. However, more developments are needed to ensure the highest safety profile.
(a) Background: In patients with sleep apnea, poor adherence to positive airway pressure (PAP) therapy has been associated with mortality. Regional studies have suggested that lower socioeconomic status is associated with worse PAP adherence but population-level data is lacking. (b) Methods: De-identified data from a nationally representative database of PAP devices was geo-linked to sociodemographic information. (c) Results: In 170,641 patients, those in the lowest quartile of median household income had lower PAP adherence (4.1 + 2.6 hrs/night; 39.6% adherent by Medicare criteria) than those in neighborhoods with highest quartile median household income (4.5 + 2.5 hrs/night; 47% adherent by Medicare criteria; p < 0.0001). In multivariate regression, individuals in neighborhoods with the highest income quartile were more adherent to PAP therapy than those in the lowest income quartile after adjusting for various confounders (adjusted Odds Ratio (adjOR) 1.18; 95% confidence interval (CI) 1.14, 1.21; p < 0.0001). Over the past decade, PAP adherence improved over time (adjOR 1.96; 95%CI 1.94, 2.01), but health inequities in PAP adherence remained even after the Affordable Care Act was passed. (d) Conclusion: In a nationally representative population, disparities in PAP adherence persist despite Medicaid expansion. Interventions aimed at promoting health equity in sleep apnea need to be undertaken.
Background
Positive airway pressure (PAP) has become a prominent treatment for children with sleep-disordered breathing. However, there are no large-scale studies to clarify whether PAP is well tolerated in children, and which factors are associated with better adherence to PAP therapy. In this study, we aimed to clarify adherence patterns of PAP therapy in a large paediatric population.
Methods
We did a cross-sectional big-data analysis in children from Oct 1, 2014, to Aug 1, 2018, using existing data derived from PAP devices uploaded nightly in the AirView cloud database. The AirView database is a usage tracking system available to all patients who are assigned PAP therapy, which requires consent from the patient or parent or guardian. All patients older than 4 years and younger than 18 years who used continuous or automated PAP devices were evaluated. Only patients living in the USA and enrolled with a single insurance company were included. If patients were participating in an engagement programme, programme onset must have been within 7 days of therapy onset. Our primary outcome was the proportion of patients who used PAP continuously over 90 days. The primary outcome was assessed in all patients who met the age inclusion criterion and had reliable age data available. Data on missing PAP use were imputed as zero, but data on other metrics were not imputed and excluded from analysis.
Findings
We used data recorded from Oct 1, 2014, to Aug 1, 2018. Of 40 140 children screened, 36 058 (89·8%) were US residents and 20 553 (90·1%) of them met the eligibility criteria and had accessible data (mean age 13·0 years [SD 3·7]). On the basis of 90 days of monitoring data, 12 699 (61·8%) patients continuously used PAP. Factors significantly associated with adherence included age group, residual apnoea–hypopnoea index, use and onset of patient engagement programmes, PAP pressure, and nightly median PAP mask leak, all over the 90-day study period.
Interpretation
To our knowledge, our study represents the largest analysis of children using PAP therapy to date. The findings suggest that adherence to PAP therapy is lower than in previous reports from adults. However, numerous actionable factors were associated with improvements in adherence and should be used strategically in clinical decision making to improve PAP adherence in children.
Funding
ResMed.
The purpose of this review was to summarize what is currently known regarding two important questions facing the field of sleep medicine today: (1) How many hours of CPAP use per night are necessary to improve daytime symptoms and reduce cardiovascular risk associated with OSA?; and (2) What strategies could be implemented to optimize adherence in clinical settings? Despite the widespread adoption of a threshold approach to CPAP management, the literature to date suggests a dose-response relationship between CPAP usage and a range of outcomes, including sleepiness, functional status, and BP; the data also suggest that the optimal adherence level differs depending on the outcome in question. Over the years, psychological measures of behavior change constructs have been increasingly recognized as the most consistent predictors of CPAP adherence, and, as such, the most successful interventions for optimizing adherence have been behavioral in nature. Unfortunately, behavioral therapies have not been translated from highly controlled research settings to comparative-effectiveness studies and finally into routine care, mainly due to feasibility and cost issues. More recently, theory-driven telemedicine adherence interventions have emerged, which take advantage of the framework that already exists in the United States and elsewhere for real-time remote-monitoring of CPAP. Combining theory-driven behavioral approaches with telemedicine technology could hold the answer to increasing real-world CPAP adherence rates, although randomized studies are still required, and socioeconomic barriers to telemedicine will need to be addressed to promote health equity.
[This corrects the article DOI: 10.1371/journal.pone.0187032.].
The purpose of this review is to conduct a systematic review and meta-analysis comparing the effects of continuous positive airway pressure (CPAP) with a mandibular advancement device (MAD) in improving the quality of life (sleepiness, cognitive, and functional outcomes) in patients diagnosed with obstructive sleep apnea (OSA). Authors identified randomized, placebo-controlled studies from MEDLINE through PubMed, Web of Science, and the Cochrane Library. Studies were assessed for inclusion and exclusion criteria, as well as risk of bias. Initial search yielded 240 unduplicated references, which the authors reduced to 12 relevant studies. Patients with CPAP therapy showed no statistically significant difference in the post-treatment quality of life measured with the SF-36 mental health component (p = .994), or the SF-36 physical functioning component (p = .827). There was no significant improvement in neither Functional Outcomes of Sleep Questionnaire (p = .788) nor cognitive performance (p = .395) compared to patients treated with oral appliances. However, the meta-analyses’ overall results showed a significant improvement in the post-treatment apnea–hypopnea index (AHI) in favor of CPAP therapy as compared with the oral appliance group (p < .001). Meta-analyses showed unclear results for sleepiness with no significant differences in average post-treatment Epworth Sleepiness Scale [ESS] (p = .203), but significant differences in change in ESS from baseline favorable to CPAP treatment (p = .047). Further studies are needed. Compliance with treatment was 1.1 h per night significantly lower with CPAP than MAD (p = .004), which could explain why though efficacy (AHI) is better with CPAP, no significant results are shown for quality of life, cognitive, and functional outcomes. Though CPAP is significantly more efficient in reducing AHI (moderate quality of evidence), it has a significantly lower compliance resulting in no differences with MAD in quality of life, cognitive, or functional outcomes. Sleep medicine professionals should monitor treatment compliance and offer patients non-compliant with CPAP an oral appliance for treatment of OSA. http://rdcu.be/ymYz
Importance
Sleep apnea (obstructive and central) is associated with adverse cardiovascular risk factors and increased risks of cardiovascular disease. Positive airway pressure (PAP) provides symptomatic relief, whether delivered continuously (CPAP) or as adaptive servo-ventilation (ASV), but the associations with cardiovascular outcomes and death are unclear.
Objective
To assess the association of PAP vs control with cardiovascular events and death in patients with sleep apnea.
Data Sources and Study Selection
MEDLINE, EMBASE, and the Cochrane Library were systematically searched from inception date to March 2017 for randomized clinical trials that included reporting of major adverse cardiovascular events or deaths.
Data Extraction and Synthesis
Two authors independently extracted data using standardized forms. Summary relative risks (RRs), risk differences (RDs) and 95% CIs were obtained using random-effects meta-analysis.
Main Outcomes and Measures
The main outcomes were a composite of acute coronary syndrome (ACS) events, stroke, or vascular death (major adverse cardiovascular events); cause-specific vascular events; and death.
Results
The analyses included data from 10 trials (9 CPAP; 1 ASV) of patients with sleep apnea (N = 7266; mean age, 60.9 [range, 51.5 to 71.1] years; 5847 [80.5%] men; mean [SD] body mass index, 30.0 [5.2]. Among 356 major adverse cardiovascular events and 613 deaths recorded, there was no significant association of PAP with major adverse cardiovascular events (RR, 0.77 [95% CI, 0.53 to 1.13]; P = .19 and RD, −0.01 [95% CI, −0.03 to 0.01]; P = .23), cardiovascular death (RR, 1.15 [95% CI, 0.88 to 1.50]; P = .30 and RD −0.00 [95% CI, −0.02 to 0.02]; P = .87), or all-cause death (RR, 1.13 [95% CI, 0.99 to 1.29]; P = .08 and RD, 0.00 [95% CI, −0.01 to 0.01]; P = .51). The same was true for ACS, stroke, and heart failure. There was no evidence of different associations for CPAP vs ASV (all P value homogeneity >.24), and meta-regressions identified no associations of PAP with outcomes for different levels of apnea severity, follow-up duration, or adherence to PAP (all P values > .13).
Conclusions and Relevance
The use of PAP, compared with no treatment or sham, was not associated with reduced risks of cardiovascular outcomes or death for patients with sleep apnea. Although there are other benefits of treatment with PAP for sleep apnea, these findings do not support treatment with PAP with a goal of prevention of these outcomes.
Study objectives:
To compare the effectiveness of a custom-made (MRDc) versus ready-made (MRDr) mandibular repositioning devices (MRD) in the management of obstructive sleep apnea (OSA).
Study design and participants:
A randomized crossover trial design was adopted in which patients with a confirmed diagnosis of OSA were randomly allocated to receive either a 3-month period of ready-made or custom-made MRD, with an intervening washout period of 2 weeks, prior to crossover. Treatment outcomes included both objective sleep monitoring and patient-centered measures (daytime sleepiness, partner snoring and quality of life).
Results:
Twenty-five patients, with a mild degree of OSA (AHI of 13.3 [10.9-25] events/h) and daytime sleepiness (ESS of 11 [6-16]), completed both arms of the trial. The MRDc achieved a complete treatment response in 64% of participants, compared with 24% with the MRDr (p < 0.001). A significant difference was observed in treatment failures, when comparing the MRDr (36%) with the MRDc (4%). Excessive daytime sleepiness (ESS ≥10) persisted in 33% (MRDc) and 66% (MRDr) of OSA subjects, following treatment. A statistically significant improvement was observed in quality of life scales following MRDc therapy only. Significant differences were observed in relation to both the number of nights per week (p = 0.004) and hours per night (p = 0.006) between the two different designs of device.
Conclusion:
The study demonstrates the significant clinical effectiveness of a custom-made mandibular repositioning device, particularly in terms of patient compliance and tolerance, in the treatment of OSA.
Background
Obstructive sleep apnea is associated with an increased risk of cardiovascular events; whether treatment with continuous positive airway pressure (CPAP) prevents major cardiovascular events is uncertain.
Methods
After a 1-week run-in period during which the participants used sham CPAP, we randomly assigned 2717 eligible adults between 45 and 75 years of age who had moderate-to-severe obstructive sleep apnea and coronary or cerebrovascular disease to receive CPAP treatment plus usual care (CPAP group) or usual care alone (usual-care group). The primary composite end point was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack. Secondary end points included other cardiovascular outcomes, health-related quality of life, snoring symptoms, daytime sleepiness, and mood.
Results
Most of the participants were men who had moderate-to-severe obstructive sleep apnea and minimal sleepiness. In the CPAP group, the mean duration of adherence to CPAP therapy was 3.3 hours per night, and the mean apnea–hypopnea index (the number of apnea or hypopnea events per hour of recording) decreased from 29.0 events per hour at baseline to 3.7 events per hour during follow-up. After a mean follow-up of 3.7 years, a primary end-point event had occurred in 229 participants in the CPAP group (17.0%) and in 207 participants in the usual-care group (15.4%) (hazard ratio with CPAP, 1.10; 95% confidence interval, 0.91 to 1.32; P=0.34). No significant effect on any individual or other composite cardiovascular end point was observed. CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood.
Conclusions
Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease. (Funded by the National Health and Medical Research Council of Australia and others; SAVE ClinicalTrials.gov number, NCT00738179; Australian New Zealand Clinical Trials Registry number, ACTRN12608000409370.)
Elevated loop gain, consequent to hypersensitive ventilatory control, is a primary nonanatomical cause of obstructive sleep apnoea (OSA) but it is not possible to quantify this in the clinic. Here we provide a novel method to estimate loop gain in OSA patients using routine clinical polysomnography alone. We use the concept that spontaneous ventilatory fluctuations due to apnoeas/hypopnoeas (disturbance) result in opposing changes in ventilatory drive (response) as determined by loop gain (response/disturbance). Fitting a simple ventilatory control model (including chemical and arousal contributions to ventilatory drive) to the ventilatory pattern of OSA reveals the underlying loop gain.
Following mathematical-model validation, we critically tested our method in patients with OSA by comparison with a standard (continuous positive airway pressure (CPAP) drop method), and by assessing its ability to detect the known reduction in loop gain with oxygen and acetazolamide.
Our method quantified loop gain from baseline polysomnography (correlation versus CPAP-estimated loop gain: n=28; r=0.63, p<0.001), detected the known reduction in loop gain with oxygen (n=11; mean± sem change in loop gain (ΔLG) −0.23±0.08, p=0.02) and acetazolamide (n=11; ΔLG −0.20±0.06, p=0.005), and predicted the OSA response to loop gain-lowering therapy.
We validated a means to quantify the ventilatory control contribution to OSA pathogenesis using clinical polysomnography, enabling identification of likely responders to therapies targeting ventilatory control.
Inclusion of the patient perspective in research need not, and must not, reduce the rigor of the research. Patient input informs the design of research components that are already a standard part of studies, such as inclusion/exclusion criteria, comparators, and outcomes. The special training and skill set of researchers guide the approaches to study design, data collection, and analysis, just as the experience and perspectives of patients, clinicians, and other stakeholders help to make the research more patient-centered and relevant to health care decisions. Physician input is needed because patient-centered outcomes research is intended to influence clinical practice. There are practical reasons to incorporate patient-centeredness in research, including improved choice of research questions and improved selection and refinement of outcomes through elicitation of stakeholder perspectives, enhanced accrual and participant retention strategies, and more appropriate dissemination and implementation strategies for findings. The promise of speeding implementation is particularly salient for PCORI, which has a legislative mandate to improve practice and reduce practice variation and disparities. PCORI proposals must include an implementation plan. Clinicians have a role in putting results into practice and should be aware of the intention of patient-centered research to enhance relevance and, ideally, trust in results by those who use them.
Objectives:
To study the effect of sleep center accreditation and Sleep Medicine board certification of physicians on patient-centered outcomes in obstructive sleep apnea (OSA).
Design:
Prospective, multicenter, comparative effectiveness study.
Setting:
Four sleep centers.
Patients:
502 patients with OSA.
Interventions:
None.
Measurements and results:
Patients at two accredited and two non-accredited centers underwent polysomnography at participating locations and completed validated questionnaires, with objective measurement of positive airway pressure (PAP) therapy adherence performed three months after therapy initiation. The proportion of patients (age 53 ± 13[SD] years; 26% women; and body mass index 33.6 ± 7.2 kg/m(2)) who were adherent to PAP therapy by Medicare guidelines (> 70% of nights with ≥ 4 h use over a 30-day period) was greater in accredited (79%) than non-accredited sites (64%; p = 0.004). After adjustment for confounding variables, patients who received care from accredited centers (odds ratio [OR] 2.2, 95% confidence interval [CI], 1.2-4.2; p = 0.016) and certified physicians (OR 2.3, 95% CI, 1.3-4.0; p = 0.005) were more likely to be adherent to PAP therapy than those who received care from non-accredited centers and non-certified physicians. Patient satisfaction was associated with greater education received from physician (OR 4.6; 95% CI 2.3-9.3); greater risk perception (OR 2.7; 95% CI 1.0-7.4); physician certification (OR 2.1; 95% CI 1.1-4.2); and inversely related to delays in care (OR 0.5; 95% CI 0.3-0.9; p < 0.05). Such delays were inversely related to accreditation-certification status (p < 0.0001).
Conclusions:
In patients with OSA, accreditation-certification status of sleep centers and physicians was associated with better PAP adherence, better patient education, better patient satisfaction, and greater timeliness.
Commentary:
A commentary on this article appears in this issue on page 251.
Citation:
Parthasarathy S; Subramanian S; Quan SF. A multicenter prospective comparative effectiveness study of the effect of physician certification and center accreditation on patient-centered outcomes in obstructive sleep apnea.
Background:
Obstructive sleep apnea is associated with considerable health risks. Although continuous positive airway pressure (CPAP) can mitigate these risks, effectiveness can be reduced by inadequate adherence to treatment. We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea.
Methods:
Using a multicenter, prospective, single-group, cohort design, we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy. The primary outcome measures were the apnea-hypopnea index (AHI; the number of apnea or hypopnea events per hour, with a score of ≥15 indicating moderate-to-severe apnea) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points from baseline). Secondary outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. Consecutive participants with a response were included in a randomized, controlled therapy-withdrawal trial.
Results:
The study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour (P<0.001); the ODI score decreased 70%, from 25.4 events per hour to 7.4 events per hour (P<0.001). Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life. In the randomized phase, the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score was significantly higher (indicating more severe apnea) among the 23 participants in the therapy-withdrawal group (25.8 vs. 7.6 events per hour, P<0.001). The ODI results followed a similar pattern. The rate of procedure-related serious adverse events was less than 2%.
Conclusions:
In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number, NCT01161420.).
Continuous positive airway pressure (CPAP) is the primary therapeutic modality for obstructive sleep apnea (OSA) management. However, despite efforts to encourage patients to comply with CPAP usage, long-term adherence remains low. Consequently, surgical intervention for OSA is considered a secondary option for patients who exhibit non-compliance with CPAP. Therefore, we conducted systematic review and meta-analysis assessed the relative effectiveness of hypoglossal nerve stimulation (HNS) treatment and alternative surgical interventions for managing OSA. Five databases were searched. Studies were included if they measured polysomnography parameters and assessed sleep apnea-related quality of life (Epworth Sleepiness Scale [ESS]) both before and after HNS, and compared these outcomes with control, CPAP, or airway surgery (uvulopalatopharyngoplasty, expansion sphincter pharyngoplasty, or tongue base surgery) groups. A total of 10 studies (2209 patients) met the inclusion criteria. Compared to other airway surgeries, the rates of post-treatment apnea-hypopnea index (AHI) < 10 and < 15 events/h were significantly lower in the HNS group (odds ratio [OR] 5.33, 95% confidence interval [CI] 1.21-23.42; and 2.73, 95% CI 1.30-5.71, respectively). Additionally, postoperative AHI was significantly lower in the HNS group than in all other airway surgery groups (AHI: mean difference [MD] -8.00, 95% CI -12.03 to-3.97 events/h). However, there were no significant differences in the rate of post-treatment AHI < 5 events/h (OR 1.93, 95% CI 0.74-5.06) or postoperative ESS score (MD 0.40, 95% CI-1.52 to 2.32) between the two groups. HNS is an effective option for selected patients with moderate-to-severe OSA and CPAP intolerance.
Importance
Hypoglossal nerve stimulation (HNS) and positive airway pressure (PAP) have been shown to improve patient-reported outcomes (PROs) in obstructive sleep apnea (OSA). However, to our knowledge, there are no data that compare change in PROs between HNS and PAP or that indicate whether HNS improves comorbid insomnia or depression in the long term.
Objectives
To determine whether HNS is associated with improvements in patient-reported sleepiness, insomnia, and depression in the long term and to compare the respective associations of HNS and PAP with improved PROs.
Design, Setting, and Participants
This retrospective cohort study used data from patients treated at the Cleveland Clinic for OSA. Participants received either HNS (referred sample) from November 1, 2015, to September 31, 2018, or PAP (previous cohort) from January 1, 2010, to December 31, 2014, for OSA. Patients were matched 3:1 for PAP:HNS based on age, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), sex, and apnea hypopnea index (AHI). Data were collected at baseline and at prespecified follow-up points. Data were analyzed from March 26, 2020, to September 9, 2021.
Exposures
Treatment with HNS vs PAP.
Main Outcomes and Measures
Data collected included AHI and Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Insomnia Severity Index (ISI), and Patient Health Questionnaire-9 (PHQ-9; depression) scores.
Results
Among 85 patients receiving HNS (mean [SD] age, 62.8 [9.5] years; 59 men [69.4%]; 77 White patients [90.6%]; mean [SD] BMI, 28.8 [3.1]), compared with 217 matched patients receiving PAP (mean [SD] age, 62.1 [9.9] years; 157 men [72.4%]; 173 White patients [81.2%]; mean [SD] BMI, 29.5 [3.1]) included in the analysis, significant improvements were seen in PHQ-9 scores for HNS vs PAP (least square means, −4.06 [95% CI, −5.34 to −2.79] vs −2.58 [95% CI, −3.35 to −1.82]; mean difference, −1.48 [95% CI, −2.78 to −0.19]) with comparable improvements in ESS, FOSQ, and ISI scores. Clinically meaningful differences were observed in 42 of 65 HNS group patients (64.6%) vs 118 PAP group patients (54.5%) for ESS scores, 29 of 49 HNS group patients (59.2%) vs 67 of 217 PAP group patients (30.9%) for FOSQ scores, 14 of 48 HNS group patients (29.2%) vs 53 of 217 PAP group patients (24.4%) for PHQ-9 scores, and 23 of 49 HNS group patients (46.9%) vs 79 of 217 PAP group patients (36.4%) for ISI scores. At the 1-year post-HNS assessment, meaningful improvements were seen in 17 of 28 patients (60.7%) for ESS scores, 11 of 20 patients (55.0%) for FOSQ scores, 7 of 23 patients (30.4%) for PHQ-9 scores, and 11 of 25 patients (44.0%) for ISI scores.
Conclusions and Relevance
In this cohort study of patients with OSA, sustained improvements in PROs were observed 1 year after HNS and were comparable to those for PAP at 3 months. These findings suggest that HNS is a viable treatment for improving insomnia and depression in patients with OSA.
Introduction:
This guideline establishes clinical practice recommendations for referring adults with obstructive sleep apnea (OSA) for surgical consultation.
Methods:
The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine, otolaryngology, and bariatric surgery to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using the GRADE process. The task force evaluated the relevant literature and the quality of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations that support the recommendations. The AASM Board of Directors approved the final recommendations.
Recommendations:
The following recommendations are intended as a guide for clinicians who treat adults with OSA. Each recommendations statement is assigned a strength ("Strong" or "Conditional"). A "Strong" recommendation (i.e., "We recommend…") is one that clinicians should follow under most circumstances. A "Conditional" recommendation is one that requires that the clinician use clinical knowledge and experience, and strongly consider the patient's values and preferences to determine the best course of action.
None:
1. We recommend that clinicians discuss referral to a sleep surgeon with adults with OSA and BMI<40 who are intolerant or unaccepting of PAP as part of a patient-oriented discussion of alternative treatment options. (STRONG).
None:
2. We recommend that clinicians discuss referral to a bariatric surgeon with adults with OSA and obesity (class II/III, BMI ≥35) who are intolerant or unaccepting of PAP as part of a patient-oriented discussion of alternative treatment options. (STRONG).
None:
3. We suggest that clinicians discuss referral to a sleep surgeon with adults with OSA, BMI<40, and persistent inadequate PAP adherence due to pressure-related side effects as part of a patient-oriented discussion of adjunctive or alternative treatment options. (CONDITIONAL).
None:
4. We suggest clinicians recommend PAP as initial therapy for adults with OSA and a major upper airway anatomic abnormality prior to consideration of referral for upper airway surgery. (CONDITIONAL).
Objectives/Hypothesis
To provide the ADHERE registry Upper Airway Stimulation (UAS) outcomes update, including analyses grouped by body mass index (BMI) and therapy discomfort.
Study Design
Prospective observational study.
Methods
ADHERE captures UAS outcomes including apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), therapy usage, patient satisfaction, clinician assessment, and safety over a 1-year period. BMI ≤32 kg/m² (BMI32) and 32 < BMI ≤35 kg/m² (BMI35) group outcomes were examined.
Results
One thousand eight hundred forty-nine patients enrolled in ADHERE, 1,019 reached final visit, 843 completed the visit. Significant changes in AHI (−20.9, P < .0001) and ESS (− 4.4, P < .0001) were demonstrated. Mean therapy usage was 5.6 ± 2.2 hr/day. Significant therapy use difference was present in patients with reported discomfort versus no discomfort (4.9 ± 2.5 vs. 5.7 ± 2.1 hr/day, P = .01). Patients with discomfort had higher final visit mean AHI versus without discomfort (18.9 ± 18.5 vs. 13.5 ± 13.7 events/hr, P = .01). Changes in AHI and ESS were not significantly different. Serious adverse events reported in 2.3% of patients. Device revision rate was 1.9%. Surgical success was less likely in BMI35 versus BMI32 patients (59.8% vs. 72.2%, P = .02). There was a significant therapy use difference: 5.8 ± 2.0 hr/day in BMI32 versus 5.2 ± 2.2 hr/day in BMI35 (P = .028).
Conclusions
Data from ADHERE demonstrate high efficacy rates for UAS. Although surgical response rate differs between BMI32 and BMI35 patient groups, the AHI and ESS reduction is similar. Discomfort affects therapy adherence and efficacy. Thus, proper therapy settings adjustment to ensure comfort is imperative to improve outcomes.
Level of Evidence
4 Laryngoscope, 2021
Study objectives:
To characterize the mandibular anterior teeth crown height as a marker of periodontal changes and bone loss as a side effect of an oral appliance (OA) worn for a minimum of 4.5 years.
Methods:
This retrospective study conducted on patients with healthy baseline periodontiu m recruited participants from consecutive sleep apnea patients treated with an OA between 2004 to 2014. Eligible participants were recalled for a follow-up visit where a periodontal exam was performed, a lateral cephalogram and dental impressions were obtained. Clinical crown height for mandibular anterior teeth and cephalometric variables were measured and compared before and after treatment. A full periodontal evaluation was performed at the follow-up visit.
Results:
21 patients enrolled with a mean treatment length of 7.9±3.3 years. For the mandibular anterior teeth, clinical crown height did not change over the evaluated period. At follow-up, all the periodontal assessed variables were within normal limits, with the mean probing depth of 1.4±0.5 mm, recession 0.6±1.1 mm and Clinical Attachment Loss (CAL) 0.8±1.0 mm. Compared to baseline, there was a significant proclination of mandibular incisors (mean increase of 5.1°) with the continued use of OA. Gingival levels were maintained with clinically insignificant changes during the observation period.
Conclusions:
Inclination of the mandibular incisors increases significantly with the use of an OA in patients with obstructive sleep apnea (OSA). Positional changes in these teeth were not associated with any measured evidence of increase in clinical crown height or gingival recession.
Study objectives:
Mandibular advancement devices (MADs) are an alternative to continuous positive airway pressure (CPAP) for the management of obstructive sleep apnea (OSA). The ORCADES study is investigating the long-term effectiveness of MAD therapy in OSA patients who refused or were intolerant with CPAP. Five-year follow-up data are presented.
Methods:
Data were available in 172/331 patients treated with a custom-made computer-aided design/computer-aided manufacturing bi-block MAD (Narval CCTM; ResMed). The primary endpoint was treatment success (≥50% decrease in apnea-hypopnea index from baseline).
Results:
Five-year treatment success rates were 52% overall, and 25%, 52% and 63%, respectively, in patients with mild, moderate or severe OSA. This reflects a decline over time versus 3-6 months (79% overall) and 2 years (68%). Rates declined in all patient subgroups, but to the greatest extent in mild OSA patients. The slight worsening of respiratory parameters over time was not associated with any relevant changes in sleepiness and symptoms. Moderate or severe OSA at baseline, treatment success at 3-6 months, and no previous CPAP use were significant independent predictors of 5-year treatment success on multivariate analysis. No new safety signals emerged during long-term follow-up. The proportion of patients using their MAD for ≥4 h/night on ≥4 days/week was 93.3%; 91.3% of patients reported device usage of ≥6 h/night at 5 years. At 5-year follow-up, 96.5% of patients reported that they wanted to continue MAD therapy.
Conclusions:
Long-term MAD therapy remained effective after 5 years in >50% of patients, with good levels of patient satisfaction and adherence.
Study Objective:
The goal of the study is to compare the treatment response achieved with a trial oral appliance (OA) to that obtained with a custom OA.
Methods:
A within-subject, repeated-measures, case-control design was performed in which 193 patients were fitted with an Apnea Guard® trial OA (AG), with the vertical dimension of occlusion (VDO) dependent on sex and tongue scallop and protruded to a target setting. Two-night sleep studies assessed response to the AG (i.e., night 1 = baseline, night 2 = AG). Eighty-four responders to the AG were subsequently assessed with a custom OA (CA), fabricated and titrated according to a conventional protocol. Comparisons were then made between the CA and AG.
Results:
Both males and females showed significant improvements in the overall and supine apnea-hypopnea index (AHI) values, independent of OA and tongue scallop (all P<0.01). Relative to the CA, the AG provided significantly greater reductions in the overall AHI values (P<0.002). Both OAs significantly reduced the nonsupine AHIs in males, but not in females. The proportion of subjects who achieved an AHI < 10 events/h was 44.0% with the CA versus 73.8% with the AG (P<0.0001). The percentages of those who achieved >50% AHI reductions with the CA and AG were 52.4% and 77.4%, respectively (P<0.002). Applying logistic regression to posttreatment AHIs obtained from the two OAs across three outcome criteria, VDO (odds ratio: 1.34–1.83, all P<0.006) and pretreatment overall AHI values (odds ratio: 0.88-1.05, all P<0.02) consistently predicted therapeutic response.
Conclusions:
The results from this study demonstrated that the AG protocol, which selectively accommodates sex and tongue scallop, provided treatment responses superior to a conventional CA protocol.
Rationale:
Limited data suggest racial disparities in continuous positive airway pressure (CPAP) adherence exist.
Objectives:
To assess if CPAP adherence varies by neighborhood racial composition at a national scale.
Methods:
Telemonitoring data from a CPAP manufacturer database were used to assess adherence in adult patients initiating CPAP therapy between November 2015 and October 2018. Mapping zip code to zip code tabulation areas (ZCTAs), age- and gender- adjusted CPAP adherence data at a neighborhood level was computed as a function of neighborhood racial composition. Secondary analyses adjusted for neighborhood education and poverty.
Measurements and main results:
Among 787,236 patients living in 26,180 ZCTAs, the prevalence of CPAP adherence was 1.3% (95% CI 1.0-1.6%) lower in neighborhoods with high (≥25%) versus low (<1%) percentage of Black residents and 1.2% (95% CI 0.9-1.5%) lower in neighborhoods with high versus low percentage of Hispanic residents (p<0.001 for both) even after adjusting for neighborhood differences in poverty and education. Mean CPAP usage was similar across neighborhoods over the first 2-days, but by 90-days, differences in CPAP usage increased to 22 min (95% CI 18-27 min) between neighborhoods with high versus low percentage of Black residents and 22 min (95% CI 17-27 min) between neighborhoods with high versus low percentage of Hispanic residents (p<0.001 for both).
Conclusions:
CPAP adherence is lower in neighborhoods with greater proportions of Black and Hispanic residents independent of education or poverty. These differences lead to a lower likelihood of meeting insurance coverage requirements for CPAP therapy, potentially exacerbating sleep health disparities.
Study Objectives
The impact of therapy with continuous positive airway pressure (CPAP) and mandibular advancement device (MAD) has not been directly compared in patients with severe obstructive sleep apnea (OSA). The purpose of this individual participant data meta-analysis was to compare the treatment effects of CPAP and titratable MAD on sleepiness, quality of life, sleep-disordered breathing severity and sleep structure in patients with severe OSA.
Methods
Randomized controlled trials (RCTs) that included severe OSA patients were identified in order to compare the impact of the two treatments. Individual data from severe OSA patients were extracted from the databases and pooled for analysis.
Results
Of the 7 studies identified, 3 crossover RCT and one parallel-group RCT corresponding to 151 patients and 249 observations (125 in the CPAP treatment arm and 124 in the MAD treatment arm) were included in the analysis. Titratable MAD had a similar impact to CPAP on major patient-centered outcomes (sleepiness and quality of life). CPAP was more effective in reducing AHI and ODI. However, the two treatments had a similar impact on sleep structure with an increase of N3 and REM sleep. Finally, treatment adherence and preference were largely in favor of MAD.
Conclusion
This meta-analysis suggests that MAD represents an effective alternative treatment in severe OSA patients intolerant to CPAP or who prefer alternate therapy.
Study objectives:
Minimal focus has been placed on variations in health care delivery for obstructive sleep apnea (OSA). This study compared positive airway pressure (PAP) usage in developing countries (Brazil and Mexico) versus a developed country (United States, US), and investigated the impact of a patient engagement tool (myAir™; ResMed) on adherence.
Methods:
De-identified data from the AirView™ database (ResMed) for patients receiving PAP therapy with wirelessly connected Air10 (AirSense and AirCurve) devices in Brazil, Mexico and the US were analyzed. Adherence was defined using US Center for Medicare and Medicaid Services (CMS) criteria (usage ≥4 h/night on ≥70% of nights in the first 90 days).
Results:
The analysis included 4,181,490 patients (Brazil: 31,672; Mexico 16,934; US: 4,132,884). 90-day CMS adherence was slightly lower in Latin America versus the US (Brazil: 71.7%; Mexico: 66.4%; US: 74.0%). Significantly fewer patients were using the patient engagement tool in Brazil (8.1%) and Mexico (2.8%) versus the US (26%; both p<0.001). Patients registered to use an engagement tool had a higher rate of CMS adherence and were twice as likely to achieve CMS adherence. Average daily usage and days with usage >4 hours in the first week were the strongest predictors of CMS adherence. Across all countries, >80% of patients meeting CMS criteria at 3 months were still using PAP therapy at 1 year, with 1-year adherences rates of >75%.
Conclusions:
Short- and long-term PAP adherence rates in Brazil and Mexico were similar to those achieved in the US. Patients who registered to use an engagement tool consistently had better adherence than those who did not.
Disparities in sleep health are important but under-recognized contributors to health disparities. Understanding the factors contributing to sleep heath disparities and developing effective interventions are critical to improving all aspects of heath. Sleep heath disparities are impacted by socio-economic status, racism, discrimination, neighborhood segregation, geography, social patterns and access to healthcare as well as by cultural beliefs necessitating a cultural appropriateness component in any intervention devised for reducing sleep health disparities. Pediatric sleep disparities require innovative and urgent intervention to establish a foundation of lifelong healthy sleep. Tapping the vast potential of technology in improving sleep health access may be an underutilized tool to reduce sleep health disparities. Identifying, implementing, replicating and disseminating successful interventions to address sleep disparities have the potential to reduce overall disparities in health and quality of life.
Study objectives:
Person-centered obstructive sleep apnea (OSA) care is a collaborative approach that is respectful of an individual's health priorities. Informed decision-making is essential to person-centered care, especially as patients age. In a feasibility study, we evaluated the effects of a new decision aid (Decide2Rest) on OSA treatment decision-making in older adults.
Methods:
Patients (aged ≥ 60 years) with newly diagnosed OSA were recruited from two healthcare systems and randomized to either Decide2Rest or a control program. Post-intervention outcomes included 1) Decisional Conflict Scale (DCS; 0-100 where 0=low and 100=high conflict), which measures perceptions of uncertainty, whether decisions reflect what matters most to patients and whether patients feel supported in decision making, 2) Preparation for Decision Making scale (PDM; 0-100 where 0=least and 100 most prepared), and OSA knowledge (0-100 where 0=poor and 100 outstanding). Multivariable linear regression models examined relationships between Decide2Rest and outcomes (DCS, PDM, OSA knowledge).
Results:
73 patients were randomized to Decide2Rest (N=36; mean age 69 years; 72% male) versus control (N= 37; mean age 69 years; 70% male). Results from the regressions, controlling for study site, indicated that the Decide2Rest program resulted in less decisional conflict (20.5 versus 32.7 on the DCS; p=.014), more preparedness for decision-making (87.8 versus 66.2 on the PDM scale; p<.001), and greater OSA knowledge (75.1 versus 65.3 OSA knowledge score; p=.04) scores than the control group.
Conclusions:
The Decide2Rest program promotes person-centered OSA decision-making for older patients with newly diagnosed OSA. Future studies are needed to optimize implementation of the program.
Clinical trial registration:
Registry: ClinicalTrials.gov, Title: Improving Older Adults' Decision Making for OSAT (eDecide2Rest), Identifier: NCT03138993, URL: https://clinicaltrials.gov/ct2/show/NCT03138993.
Background:
Although highly effective in the treatment of obstructive sleep apnoea (OSA), continuous positive airway pressure (CPAP) is not universally accepted by users. Educational, supportive and behavioural interventions may help people with OSA initiate and maintain regular and continued use of CPAP.
Objectives:
To assess the effectiveness of educational, supportive, behavioural, or mixed (combination of two or more intervention types) strategies that aim to encourage adults who have been prescribed CPAP to use their devices.
Search methods:
Searches were conducted on the Cochrane Airways Group Specialised Register of trials. Searches are current to 29 April 2019.
Selection criteria:
We included randomised controlled trials (RCTs) that assessed intervention(s) designed to inform participants about CPAP/OSA, to support them in using CPAP, or to modify their behaviour to increase use of CPAP devices.
Data collection and analysis:
We assessed studies to determine their suitability for inclusion in the review. Data were extracted independently and were entered into RevMan for analysis. 'Risk of bias' assessments were performed, using the updated 'Risk of bias 2' tool, for the primary outcome, CPAP usage. Study-level 'Risk of bias' assessments were performed using the original 'Risk of bias' tool. GRADE assessment was performed using GRADEpro.
Main results:
Forty-one studies (9005 participants) are included in this review; 16 of these studies are newly identified with updated searches. Baseline Epworth Sleepiness Scale (ESS) scores indicate that most participants suffered from excessive daytime sleepiness. The majority of recruited participants had not used CPAP previously. When examining risk of bias for the primary outcome of hourly machine usage/night, 58.3% studies have high overall risk (24/41 studies), 39.0% have some concerns (16/41 studies), and 2.4% have low overall risk (1/41 studies). We are uncertain whether educational interventions improve device usage, as the certainty of evidence was assessed as very low. We were unable to perform meta-analyses for number of withdrawals and symptom scores due to high study heterogeneity. Supportive interventions probably increase device usage by 0.70 hours/night (95% confidence interval (CI) 0.36 to 1.05, N = 1426, 13 studies, moderate-certainty evidence), and low-certainty evidence indicates that the number of participants who used their devices ≥ 4 hours/night may increase from 601 to 717 per 1000 (odds ratio (OR), 1.68, 95% CI 1.08 to 2.60, N = 376, 2 studies). However, the number of withdrawals may also increase from 136 to 167 per 1000 (OR 1.27, 95% CI 0.97 to 1.66, N = 1702, 11 studies, low-certainty evidence). Participants may experience small improvements in symptoms (ESS score -0.32 points, 95% CI -1.19 to 0.56, N = 470, 5 studies, low-certainty evidence), and we are uncertain whether quality of life improves with supportive interventions, as the certainty of evidence was assessed as very low. When compared with usual care, behavioural interventions produce a clinically-meaningful increase in device usage by 1.31 hours/night (95% CI 0.95 to 1.66, N = 578, 8 studies, high-certainty evidence), probably increase the number of participants who used their machines ≥ 4 hours/night from 371 to 501 per 1000 (OR 1.70, 95% CI 1.20 to 2.41, N = 549, 6 studies, high-certainty evidence), and reduce the number of study withdrawals from 146 to 101 per 1000 (OR 0.66, 95% CI 0.44 to 0.98, N = 939, 10 studies, high-certainty evidence). Behavioural interventions may reduce symptoms (ESS score -2.42 points, 95% CI -4.27 to -0.57, N = 272, 5 studies, low-certainty evidence), but probably have no effect on quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ), standardised mean difference (SMD) 0.00, 0.95% CI -0.26 to 0.26, N = 228, 3 studies, moderate-certainty evidence). We are uncertain whether behavioural interventions improve apnoea hypopnoea index (AHI), as the certainty of evidence was assessed as very low. We are uncertain if mixed interventions improve device usage, increase the number of participants using their machines ≥ 4 hours/night, reduce study withdrawals, improve quality of life, or reduce anxiety symptoms, as the certainty of evidence for these outcomes was assessed to be very low. Symptom scores via the ESS could not be measured due to considerable heterogeneity between studies.
Authors' conclusions:
In CPAP-naïve people with OSA, high-certainty evidence indicates that behavioural interventions yield a clinically-significant increase in hourly device usage when compared with usual care. Moderate certainty evidence shows that supportive interventions increase usage modestly. Very low-certainty evidence shows that educational and mixed interventions may modestly increase CPAP usage. The impact of improved CPAP usage on daytime sleepiness, quality of life, and mood and anxiety scores remains unclear since these outcomes were not assessed in the majority of included studies. Studies addressing the choice of interventions that best match individual patient needs and therefore result in the most successful and cost-effective therapy are needed.
Background
The goal of this study was to review relevant randomized controlled trials in order to determine the efficacy of continuous positive airway pressure (CPAP) versus mandibular advancement device (MAD) in the treatment of obstructive sleep apnea (OSA).
Methods
Using appropriate keywords, we identified relevant studies using PubMed, the Cochrane Library, and Embase. Key pertinent sources in the literature were also reviewed, and all articles published through October 2019 were considered for inclusion. For each study, we used odds ratios (ORs), mean difference (MD), and 95% confidence interval (95% CI) to assess and synthesize outcomes.
Results
We included 14 RCTs, for a total of 249 patients in the CPAP group and 247 in the MAD group. Compared with MAD, CPAP significantly decreased apnea hypopnea index (WMD: -7.08, 95%CI: -9.06∼-5.10) and the percentage of stage 1 and 2 after therapy (WMD: -3.728, 95%CI: -6.912∼-0.543). However, compared with MAD, CPAP significantly decreased the SF-36-social function score (WMD: -3.381, 95%CI: -6.607∼-0.154).There was no significant difference in Epworth sleepiness scale score after therapy between the two groups.
Conclusion
CPAP has better therapeutic efficacy in OSA patients than MAD.
Study objectives:
Obstructive sleep apnea syndrome (OSAS) is a sleep related breathing disorder, commonly treated by either Continuous Positive Airway Pressure (CPAP) or a Mandibular Advancement Device (MAD). Long-term follow-up and comparison regarding efficacy of these therapies is scarce. In this study the results of treatment, patient compliance and satisfaction over a 10-year follow-up of these therapies are reported.
Methods:
This is a longitudinal follow-up study taken from a subset of patients initially enrolled in a randomized controlled clinical trial of 103 OSAS patients (51 and 52 patients randomized for MAD and CPAP respectively). After a 10-year follow-up period, 14 patients using MAD and 17 patients using CPAP could be evaluated for this longitudinal follow-up study. Data was analyzed at baseline, after 3-months and at 1, 2, and 10-year follow-up. All 31 OSAS patients were subjected to polysomnography and subjective measurements.
Results:
Polysomnography showed a favorable outcome of both therapies at 10-year follow-up. At baseline, included patients in both groups did not significantly differ in apnea-hypopnea index (AHI) values. At 10-year follow-up both, MAD and CPAP group, showed a significant reduction in AHI. At baseline the mean AHI in MAD group was 31.7±20.6 whereas in the CPAP group 49.2±26.1. At 10-year follow-up the mean AHI in MAD group was 9.9±10.3 and in the CPAP group 3.4±5.4. From a subjective perspective both therapies resulted in a substantial improvement in neurobehavioral outcomes at 10-year follow-up.
Conclusions:
Both CPAP and MAD therapy demonstrate good and stable treatment effects after a 10-year follow-up period. Therefore, when indicated, both therapies are appropriate modalities for the long-term management of OSAS.
Background:
The evidence base for the treatment of mild obstructive sleep apnoea is limited and definitions of disease severity vary. The MERGE trial investigated the clinical effectiveness of continuous positive airway pressure in patients with mild obstructive sleep apnoea.
Methods:
MERGE, a multicentre, parallel, randomised controlled trial enrolled patients (≥18 years to ≤80 years) with mild obstructive sleep apnoea (apnoea-hypopnoea index [AHI] ≥5 to ≤15 events per h using either AASM 2007 or AASM 2012 scoring criteria) from 11 UK sleep centres. Participants were assigned (1:1) to either 3 months of continuous positive airway pressure plus standard care (sleep counselling), or standard care alone, by computer-generated randomisation; neither participants nor researchers were blinded. The primary outcome was a change in the score on the Short Form-36 questionnaire vitality scale in the intention-to-treat population of patients with mild obstructive sleep apnoea diagnosed using the American Academy of Sleep Medicine 2012 scoring criteria. The study is registered with ClinicalTrials.gov, NCT02699463.
Findings:
Between Nov 28, 2016 and Feb 12, 2019, 301 patients were recruited and randomised. 233 had mild obstructive sleep apnoea using AASM 2012 criteria and were included in the intention-to-treat analysis: 115 were allocated to receive continuous positive airway pressure and 118 to receive standard care. 209 (90%) of these participants completed the trial. The vitality score significantly increased with a treatment effect of a mean of 10·0 points (95% CI 7·2-12·8; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (9·2 points [6·8 to 11·6] vs -0·8 points [-3·2 to 1·5]). Using the ANCOVA last-observation-carried-forward analysis, a more conservative estimate, the vitality score also significantly increased with a treatment effect of a mean of 7·5 points (95% CI 5·3 to 9·6; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (7·5 points [6·0 to 9·0] vs 0·0 points [-1·5 to 1·5]). Three serious adverse events occurred (one allocated to the continuous positive airway pressure group) and all were unrelated to the intervention.
Interpretation:
3 months of treatment with continuous positive airway pressure improved the quality of life in patients with mild obstructive sleep apnoea. These results highlight the need for health-care professionals and providers to consider treatment for patients with mild obstructive sleep apnoea.
Funding:
ResMed Ltd.
Mandibular advancement device (MAD) therapy is the most commonly used non-continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). Although OSA patients prefer MAD over CPAP, on average over one third have minimal or no major reduction in OSA severity with MAD therapy. Improved understanding of responder characteristics (or “phenotypes”) to MAD may facilitate more efficient use of limited medical resources and optimize treatment efficacy.
The aim of this review is to describe the baseline phenotypic characteristics of responders to MAD therapy in OSA patients. Pubmed, Web of Science, EMBASE, Scopus were searched for eligible studies published until Feb 2019. A total of 650 studies were identified. 41 studies were included in this review and meta-analysis. The quality of the studies was assessed using the risk of bias assessment tool for non-randomized studies (RoBANS). Based on meta-analysis, the responders to MAD therapy had certain clinical phenotypic characteristics: lower age (95% CI: −4.55 to −1.62, p < 0.00001), female (95% CI: 0.56 to 0.91, p = 0.006), lower body mass index (95% CI: −2.80 to −1.11, p < 0.00001), smaller neck circumference (95% CI: −1.57 to −0.52, p < 0.00001), lower apnea-hypopnea index (95% CI: −7.23 to −1.89, p < 0.00001), a retracted maxilla and mandible, a narrower airway and a shorter soft palate than non-responders. The above-mentioned phenotypic responder characteristics provides useful information for the clinician when considering prescribing MAD therapy for OSA patients.
Qualitative methods are a valuable tool in implementation research because they help to answer complex questions such as how and why efforts to implement best practices may succeed or fail, and how patients and providers experience and make decisions in care. This article orients the novice implementation scientist to fundamentals of qualitative methods and their application in implementation research, describing: 1) implementation-related questions that can be addressed by qualitative methods; 2) qualitative methods commonly used in implementation research; 3) basic sampling and data collection procedures; and 4) recommended practices for data analysis and ensuring rigor. To illustrate qualitative methods decision-making, a case example is provided of a study examining implementation of a primary care-based collaborative care management model for women Veterans with anxiety, depression, and PTSD.
Background and objective:
Continuous positive airway pressure (CPAP) is the first-line therapy for obstructive sleep apnoea (OSA). Residual apnoea and/or hypopnoea events, that is an apnoea-hypopnoea index (AHI) > 5, during CPAP contribute to treatment drop-out. The clinical scenarios triggering residual events during CPAP use are poorly described. Underlying co-morbidities, especially cardiovascular diseases, lifestyle factors, OSA characteristics at diagnosis and type of mask have been suggested as potential contributors.
Methods:
Patients from the prospective French sleep apnoea registry diagnosed with OSA (AHI ≥ 15 events/h) treated with CPAP were included. Logistic regression analysis identified factors associated with a risk of residual AHI > 5 events/h on CPAP.
Results:
The 12 285 OSA patients were predominantly men (n = 8715, 70.9%), middle-aged (58.2 (49.8; 66.1) years) and obese (median body mass index: 31.3 (27.7; 35.6) kg/m2 ). Most had an AHI ≤ 5 events/h (n = 9573, 77.9%) versus 22.1% with AHI > 5/h. The latter were less CPAP adherent (5.75 (4.01; 7.00) vs 6.00 (4.53; 7.00) h/night). In multivariable analysis, factors associated with residual AHI >5/h were male sex, age, sedentary lifestyle, OSA severity, cardiovascular co-morbidities (heart failure and arrhythmia) and type of interface (orofacial mask versus nasal mask: OR = 2.15 (95%CI: 1.95; 2.37)). A subgroup analysis found that patients using pressures above 10 cm H2 O were 1.43 (95% CI: 1.3; 1.57) times more likely to have residual AHI > 5/h.
Conclusion:
Knowing about risk factors for residual apnoeic-hypopnoeic events may assist in the timely provision of personalized care including the type of PAP therapy, attention to co-morbidities and choice of interface.
Study objectives:
To (1) describe outcomes from a computer decision support system (CDSS) for pediatric obstructive sleep apnea (OSA) detection in primary care; and (2) identity the prevalence of children meeting criteria for an OSA referral.
Methods:
A CDSS for OSA was implemented in two urban primary care clinics. Parents of children (age 2 to 11 years) presenting to the clinic were asked if their child snored regularly, with a positive response resulting in six additional OSA screening items. Primary care providers (PCPs) received a prompt for all snoring children, listing applicable OSA signs and symptoms and recommending further evaluation and referral for OSA.
Results:
A total of 2,535 children were screened for snoring, identifying 475 snoring children (18.7%). Among snoring children, PCPs referred 40 (15.4%) for further evaluation. The prevalence of additional OSA signs and symptoms ranged from 3.5% for underweight to 43.7% for overweight. A total of 74.7% of snoring children had at least one additional sign or symptom and thus met American Academy of Pediatrics guidelines criteria for an OSA referral.
Conclusions:
A CDSS can be used to support PCPs in identifying children at risk for OSA. Most snoring children met criteria for further evaluation. It will be important to further evaluate this referral threshold as well as the readiness of the sleep medicine field to meet this need.
Clinical trials registration:
Registry: ClinicalTrials.gov, Title: Evidence-based Diagnosis and Management of Pediatric Obstructive Sleep Apnea in Primary Care, Identifier: NCT02781376, URL: https://clinicaltrials.gov/ct2/show/NCT02781376.
Introduction:
The purpose of this systematic review is to provide supporting evidence for the clinical practice guideline for the treatment of obstructive sleep apnea (OSA) in adults using positive airway pressure (PAP).
Methods:
The American Academy of Sleep Medicine commissioned a task force of experts in sleep medicine. A systematic review was conducted to identify studies that compared the use of PAP with no treatment as well as studies that compared different PAP modalities. Meta-analyses were performed to determine the clinical significance of using PAP in several modalities (ie, continuous PAP, auto-adjusting PAP, and bilevel PAP), to treat OSA in adults. In addition, meta-analyses were performed to determine the clinical significance of using an in-laboratory versus ambulatory strategy for the initiation of PAP, educational and behavioral interventions, telemonitoring, humidification, different mask interfaces, and flexible or modified pressure profile PAP in conjunction with PAP to treat OSA in adults. Finally, the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence for making recommendations.
Results:
The literature search resulted in 336 studies that met inclusion criteria; 184 studies provided data suitable for meta-analyses. The data demonstrated that PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor vehicle accidents, and improvement in sleep-related quality of life in adults with OSA. In addition, the initiation of PAP in the home demonstrated equivalent effects on patient outcomes when compared to an in-laboratory titration approach. The data also demonstrated that the use of auto-adjusting or bilevel PAP did not result in clinically significant differences in patient outcomes compared with standard continuous PAP. Furthermore, data demonstrated a clinically significant improvement in PAP adherence with the use of educational, behavioral, troubleshooting, and telemonitoring interventions. Systematic reviews for specific PAP delivery method were also performed and suggested that nasal interfaces compared to oronasal interfaces have improved adherence and slightly greater reductions in OSA severity, heated humidification compared to no humidification reduces some continuous PAP-related side effects, and pressure profile PAP did not result in clinically significant differences in patient outcomes compared with standard continuous PAP.
Objective/background:
The Clinical Global Impression scale (CGI) reflects the clinician's assessment of the disease impact on patient's global functioning. We assessed predictors of CGI scale rating in patients with obstructive sleep apnea (OSA).
Patients/methods:
Consecutive patients with suspected OSA (n = 7581) were identified in the European Sleep Apnea Database (ESADA). Anthropometrics, comorbidities, apnea severity obtained by polygraphy or polysomnography, and daytime sleepiness [Epworth Sleepiness Scale (ESS)] were assessed. The CGI 7-point scale was completed at the end of the diagnostic process (CGI-severity, ie, CGI-S) and, in a subpopulation, at treatment follow-up (CGI-Improvement).
Results:
CGI-S was rated mild to moderate in 44% of patients. CGI rating at any given apnea intensity was worse in women than in men (p < 0.01). Patients undergoing polygraphy (n = 5075) were more frequently rated as severely ill compared to those studied with polysomnography (19.0% vs 13.0%, p < 0.001). In patients aged ≤65 years, CGI scoring was generally better than in the elderly despite a similar degree of OSA (eg, 'normal, not ill' 24.2% vs 15.3%, p < 0.01, respectively). Independent predictors of CGI rating included age, BMI, AHI, ESS, cardio-metabolic comorbidities, and diagnosis based on polygraphy. CGI-improvement rating (Beta = -0.406, p < 0.01) was superior to sleep apnea severity or ESS-score (Beta = 0.052 and -0.021, p = 0.154 and 0.538 respectively) at baseline for prediction of good CPAP compliance at follow-up.
Conclusions:
CGI rating is confounded by gender, age class and the type of sleep diagnostic method. As OSA phenotypes differ, CGI may contribute as a clinical tool to reflect the significance of clinical disease.
It is increasingly recognized that the high prevalence of obstructive sleep apnoea (OSA), and its associated cardio-metabolic morbidities make OSA a burden for society. Continuous positive airway pressure (CPAP), the gold standard treatment, needs to be used for more than 4 h/night to be effective, but suffers from relatively poor adherence. Furthermore, CPAP is likely to be more effective if combined with lifestyle changes. Thus, the remote telemonitoring (TM) of OSA patients in terms of CPAP use, signalling of device problems, following disease progression, detection of acute events and monitoring of daily physical activity is an attractive option. In the present review, we aim to summarize the recent scientific data on remote TM of OSA patients, and whether it meets expectations. We also look at how patient education and follow-up via telemedicine is used to improve adherence and we discuss the influence of the profile of the healthcare provider. Then, we consider how TM might be extended to encompass the patient's cardio-metabolic health in general. Lastly, we explore how TM and the deluge of data it potentially generates could be combined with electronic health records in providing personalized care and multi-disease management to OSA patients.
Rationale:
Automated telemedicine interventions could potentially improve adherence to continuous positive airway pressure (CPAP) therapy.
Objectives:
Examining the effects of telemedicine-delivered obstructive sleep apnea (OSA) education and CPAP telemonitoring with automated patient feedback messaging on CPAP adherence.
Methods:
This four-arm, randomized, factorial design clinical trial enrolled 1,455 patients (51.0% women; age, 49.1 ± 12.5 yr [mean ± SD]) referred for suspected OSA. Nine hundred and fifty-six underwent home sleep apnea testing, and 556 were prescribed CPAP. Two telemedicine interventions were implemented: 1) web-based OSA education (Tel-Ed) and 2) CPAP telemonitoring with automated patient feedback (Tel-TM). Patients were randomized to 1) usual care, 2) Tel-Ed added, 3) Tel-TM added, or 4) Tel-Ed and Tel-TM added (Tel-both).
Measurements and main results:
The primary endpoint was 90-day CPAP usage. Secondary endpoints included attendance to OSA evaluation, and change in Epworth Sleepiness Scale score. CPAP average daily use at 90 days was 3.8 ± 2.5, 4.0 ± 2.4, 4.4 ± 2.2, and 4.8 ± 2.3 hours in usual care, Tel-Ed, Tel-TM, and Tel-both groups. Usage was significantly higher in the Tel-TM and Tel-both groups versus usual care (P = 0.0002 for both) but not for Tel-Ed (P = 0.10). Medicare adherence rates were 53.5, 61.0, 65.6, and 73.2% in usual care, Tel-Ed, Tel-TM, and Tel-both groups (Tel-both vs. usual care, P = 0.001; Tel-TM vs. usual care, P = 0.003; Tel-Ed vs. usual care, P = 0.07), respectively. Telemedicine education improved clinic attendance compared with no telemedicine education (show rate, 68.5 vs. 62.7%; P = 0.02).
Conclusions:
The use of CPAP telemonitoring with automated feedback messaging improved 90-day adherence in patients with OSA. Telemedicine-based education did not significantly improve CPAP adherence but did increase clinic attendance for OSA evaluation. Clinical trial registered with www.clinicaltrials.gov (NCT02279901).
A wealth of scientific knowledge is being generated in sleep and circadian science. In order for us to realize the return on investment for such scientific knowledge and to improve the health of the nation, we need to disseminate and implement research findings into practice. An implementation gap - termed a "quality chasm" by the Institutes of Medicine - separates the scientific knowledge we possess and the implementation of such knowledge into preventative interventions or healthcare treatments. It is frequently reported that a time lag of 17 years transpires before medical research reaches clinical practice. The rapid development of new therapies and devices for sleep and circadian disorders, the emergence of wearable devices and mobile health, combined with the mounting interest in sleep from the public and technology industries, present a transformative opportunity for sleep and circadian science researchers. In order to capitalize on this opportunity, the Sleep Research Society and the National Institutes of Health partnered to organize a workshop focused on the translation of evidence-based interventions for sleep and circadian disorders into practice strategies that benefit population health and patient outcomes. The workshop drew on the collective expertise of implementation scientists and sleep scientists in the areas of insomnia, sleep-disordered breathing, and adolescent sleep health. Together, they identified implementation gaps, effective interventions, implementation strategies and relevant outcomes and created a set of recommendations that could accelerate late-stage translation of sleep and circadian rhythms research findings to benefit public health. This white paper represents the proceedings and consensus developed at the workshop. The recommendations for high-priority implementation research are targeted at sleep and implementation researchers, educators, patients, professional societies, industry partners, funding-decision and policy makers. The major recommendations for implementation science in sleep and circadian sciences were to address the following high priority future research needs: (1) Costs and economic benefits associated with screening, diagnosing, treating insomnia across different systems (health care system, employers, etc.). (2) Promoting health literacy and education of patients, providers and community stakeholders regarding obstructive sleep apnea. (3) Increase the proportion of students in grades 9 through 12 who get sufficient sleep and (4) Perform trials aimed at improving adherence to treatments for sleep-disordered breathing (particularly evaluating cognitive therapy approaches). The fourth priority area was identified as an important barrier to implementation science efforts in sleep.
Background:
Many advances in health care fail to reach patients. Implementation science is the study of novel approaches to mitigate this evidence-to-practice gap.
Methods:
The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement on implementation science in pulmonary, critical care, and sleep medicine. The committee used an iterative consensus process to define implementation science and review the use of conceptual frameworks to guide implementation science for the pulmonary, critical care, and sleep community and to explore how professional medical societies such as the ATS can promote implementation science.
Results:
The committee defined implementation science as the study of the mechanisms by which effective health care interventions are either adopted or not adopted in clinical and community settings. The committee also distinguished implementation science from the act of implementation. Ideally, implementation science should include early and continuous stakeholder involvement and the use of conceptual frameworks (i.e., models to systematize the conduct of studies and standardize the communication of findings). Multiple conceptual frameworks are available, and we suggest the selection of one or more frameworks on the basis of the specific research question and setting. Professional medical societies such as the ATS can have an important role in promoting implementation science. Recommendations for professional societies to consider include: unifying implementation science activities through a single organizational structure, linking front-line clinicians with implementation scientists, seeking collaborations to prioritize and conduct implementation science studies, supporting implementation science projects through funding opportunities, working with research funding bodies to set the research agenda in the field, collaborating with external bodies responsible for health care delivery, disseminating results of implementation science through scientific journals and conferences, and teaching the next generation about implementation science through courses and other media.
Conclusions:
Implementation science plays an increasingly important role in health care. Through support of implementation science, the ATS and other professional medical societies can work with other stakeholders to lead this effort.
Obstructive sleep apnea is a common disorder that has been associated with an increased risk of cardiovascular disease.1 Continuous positive airway pressure (CPAP) is frequently prescribed in patients with obstructive sleep apnea and is effective in reversing hypoxemia and upper airway obstruction. Meta-analyses of randomized trials have shown that CPAP therapy elicits significant reductions in systemic arterial pressure, and the effect is greater with higher adherence.2,3 Observational studies have shown significantly fewer cardiovascular events in patients adherent to CPAP therapy than in those who are not adherent,4,5 but the need for large trials has lingered. The Sleep Apnea . . .
Since the previous parameter and review paper publication on oral appliances (OAs) in 2006, the relevant scientific literature has grown considerably, particularly in relation to clinical outcomes. The purpose of this new guideline is to replace the previous and update recommendations for the use of OAs in the treatment of obstructive sleep apnea (OSA) and snoring.
The American Academy of Sleep Medicine (AASM) and American Academy of Dental Sleep Medicine (AADSM) commissioned a seven-member task force. A systematic review of the literature was performed and a modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the quality of evidence. The task force developed recommendations and assigned strengths based on the quality of the evidence counterbalanced by an assessment of the relative benefit of the treatment versus the potential harms. The AASM and AADSM Board of Directors approved the final guideline recommendations.
1. We recommend that sleep physicians prescribe oral appliances, rather than no therapy, for adult patients who request treatment of primary snoring (without obstructive sleep apnea). (STANDARD); 2.When oral appliance therapy is prescribed by a sleep physician for an adult patient with obstructive sleep apnea, we suggest that a qualified dentist use a custom, titratable appliance over non-custom oral devices. (GUIDELINE); 3. We recommend that sleep physicians consider prescription of oral appliances, rather than no treatment, for adult patients with obstructive sleep apnea who are intolerant of CPAP therapy or prefer alternate therapy. (STANDARD); 4. We suggest that qualified dentists provide oversight-rather than no follow-up-of oral appliance therapy in adult patients with obstructive sleep apnea, to survey for dental-related side effects or occlusal changes and reduce their incidence. (GUIDELINE); 5. We suggest that sleep physicians conduct follow-up sleep testing to improve or confirm treatment efficacy, rather than conduct follow-up without sleep testing, for patients fitted with oral appliances. (GUIDELINE); 6.We suggest that sleep physicians and qualified dentists instruct adult patients treated with oral appliances for obstructive sleep apnea to return for periodic office visits-as opposed to no follow-up-with a qualified dentist and a sleep physician. (GUIDELINE).
The AASM and AADSM expect these guidelines to have a positive impact on professional behavior, patient outcomes, and, possibly, health care costs. This guideline reflects the state of knowledge at the time of publication and will require updates if new evidence warrants significant changes to the current recommendations.
Copyright © 2015 American Academy of Sleep Medicine. All rights reserved.
To determine the clinical variables that best predict long- term continuous positive airway pressure (CPAP) adherence among patients with cardiovascular disease who have obstructive sleep apnea (OSA).
12-mo prospective within-trial observational study.
Centers in China, Australia, and New Zealand participating in the Sleep Apnea cardioVascular Endpoints (SAVE) study.
There were 275 patients age 45-70 y with cardiovascular disease (i.e., previously documented transient ischemic attack, stroke, or coronary artery disease) and OSA (4% oxygen desaturation index (ODI) > 12) who were randomized into the CPAP arm of the SAVE trial prior to July 1, 2010.
Age, sex, country of residence, type of cardiovascular disease, baseline ODI, severity of sleepiness, and Hospital Anxiety and Depression Scale (HADS) scores plus CPAP side effects and adherence at 1 mo were entered in univariate analyses in an attempt to identify factors predictive of CPAP adherence at 12 mo. Variables with P < 0.2 were then included in a multivariate analysis using a linear mixed model with sites as a random effect and 12-mo CPAP use as the dependent outcome variable.
CPAP adherence at 1, 6, and 12 mo was (mean ± standard deviation) 4.4 ± 2.0, 3.8 ± 2.3, and 3.3 ± 2.4 h/night, respectively. CPAP use at 1 mo (effect estimate ± standard error, 0.65 ± 0.07 per h increase, P < 0.001) and side effects at 1 mo (-0.24 ± 0.092 per additional side effect, P = 0.009) were the only independent predictors of 12- mo CPAP adherence.
Continuous positive airway pressure use in patients with coexisting cardiovascular disease and moderate to severe obstructive sleep apnea decreases significantly over 12 months. This decline can be predicted by early patient experiences with continuous positive airway pressure (i.e., adherence and side effects at 1 month), raising the possibility that intensive early interventions could improve long-term continuous positive airway pressure compliance in this patient population.
Clinical Trials, http://www.clinicaltrials.gov, NCT00738179.
Chai-Coetzer CL; Luo YM; Antic NA; Zhang XL; Chen BY; He QY; Heeley E; Huang SG; Anderson C; Zhong NS; McEvoy RD. Predictors of long-term adherence to continuous positive airway pressure therapy in patients with obstructive sleep apnea and cardiovascular disease in the SAVE study. SLEEP 2013;36(12):1929-1937.